Post Marketing Surveillance to Monitor the Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered According to the Prescribing Information to Indian Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)
研究概览
简要总结
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Weeks 至 167 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS.
- •A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
排除标准
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Acute disease at the time of enrolment.
- •Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception.
- •Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
- •Gastroenteritis within 7 days preceding vaccination.
结局指标
主要结局
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)
时间窗: During the 8-day (Day 0 - Day 7) follow-up period after each vaccination.
Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day.
次要结局
- Number of Subjects Reporting Solicited General Symptoms(During the 8-day (Day 0 - Day 7) follow-up period after each vaccination)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(During the 31-day (Day 0 - Day 30) follow-up period after each vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Throughout the study period (from Day 0 up to Day 30))